Endothelial FunctionNCT01085019
Impact of Spices and Herbs on Endothelial Function
A study testing Cinnamon, Oregano and Ginger in people with Endothelial Function, run by Laval University at 2 sites in Canada.
Trial summary
The general objective of the study is to investigate the effects of the daily consumption of spices and herbs for four (4) consecutive weeks in endothelial function and cardiovascular risk factors of men and postmenopausal women. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Function
- What is being tested?
- Cinnamon, Oregano and Ginger
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 40-70 yrs
- Men and postmenopausal women
- Waist girth >102cm (men) or >88cm (women)
- LDL-C > 2.8 mmol/L
- Framingham 10-yr risk score < 10%
- Marginal endothelial dysfunction
- Non smoker
Who cannot join
- Medication for lipid, hypertension, diabetes
- History of CVD, diabetes, other endocrines disorders
- Pre-menopausal women
- Alcohol consumption > 1 drink per day
- Unusual dietary habits (e.g. vegetarism)
- Chronic use of supplements (estrogens, vitamins, minerals or flavonoids)
- Aversion or intolerance for spices and/or herbs
- Injury to fingers or amrs that would interfere with endothelial function measurement
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Institute of Nutraceuticals and Functional Foods
Québec, Quebec, G1V 0A6
Richardson Centre of Functional Foods and Nutracuticals
Winnipeg, Manitoba, R3T 6C5
About this study
Official title: Investigation of the Impact of Spices and Herbs on Endothelial Function and Other CVD Risk Factors in Men and Women.
The general objective of the study is to investigate the effects of the daily consumption of spices and herbs for four (4) consecutive weeks in endothelial function and cardiovascular risk factors of men and postmenopausal women.
Read the detailed description
The purpose is to assess whether the polyphenol/antioxidant content of different spices will affect endothelial function and other cardiovascular risk factors.
- Conditions
- Endothelial Function
- Being tested
- Cinnamon, Oregano, Ginger, Rosemary, Black pepper
- Keywords
- Endothelial function, Cardiovascular risk factors, Spices, Herbs, Antioxidant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinnamonDietary supplement
2.8g/day of cinnamon in capsules during 4 weeks.
OreganoDietary supplement
2.8g/day of oregano in capsules during 4 weeks.
GingerDietary supplement
2.8g/day of ginger in capsules during 4 weeks.
RosemaryDietary supplement
2.8g/day of rosemary in capsules during 4 weeks.
Black pepperDietary supplement
2.8g/day of black pepper in capsules for 4 weeks.
PlaceboDietary supplement
2.8 g/day of placebo in capsules (corn starch) during 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement: Cinnamon | Experimental | Not described Receives: Dietary Supplement: Cinnamon |
| Dietary supplement: Oregano | Experimental | Not described Receives: Dietary Supplement: Oregano |
| Dietary supplement: Ginger | Experimental | Not described Receives: Dietary Supplement: Ginger |
| Dietary supplement: Rosemary | Experimental | Not described Receives: Dietary Supplement: Rosemary |
| Dietary supplement: Black pepper | Experimental | Not described Receives: Dietary Supplement: Black pepper |
| Dietary supplement: Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function measured by endopat system (the endothelium-mediated changes in vacular tone)
Measured: at week 0 and week 4
Secondary outcomes (3)
Circulating level of plasma lipoproteins-lipids
Measured: at week 0 and week 4
Oxidative stress
Measured: at week 0 and week 4
Endothelial activation and inflammatory markers
Measured: at week 0 and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endothelial FunctionStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- McCormick Canada Co
- Responsible party
- Principal investigator, Charles Couillard, Laval University
- Investigators
- Charles Couillard, Ph.D, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085019
- Sponsor's protocol ID
- INAF-2009-253
- Status last verified
- Jun 2012
- First submitted
- 9 Mar 2010
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Carnovale V, Paradis ME, Gigleux I, Ramprasath VR, Couture P, Jones PJ, Lamarche B, Couillard C. Correlates of reactive hyperemic index in men and postmenopausal women. Vasc Med. 2013 Dec;18(6):340-6. doi: 10.1177/1358863X13507975.
PubMed 24292639
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Impact of Spices and Herbs on Endothelial Function and Other CVD Risk Factors in Men and Women.
- ClinicalTrials.gov ID
- NCT01085019
- Acronym / sponsor ID
- INAF-2009-253
- Conditions
- Endothelial Function
- Keywords
- Endothelial function, Cardiovascular risk factors, Spices, Herbs, Antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- McCormick Canada Co
- Study start
- Mar 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The general objective of the study is to investigate the effects of the daily consumption of spices and herbs for four (4) consecutive weeks in endothelial function and cardiovascular risk factors of men and postmenopausal women.
Detailed description
The purpose is to assess whether the polyphenol/antioxidant content of different spices will affect endothelial function and other cardiovascular risk factors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement: Cinnamon | Experimental | Dietary Supplement: Cinnamon |
| Dietary supplement: Oregano | Experimental | Dietary Supplement: Oregano |
| Dietary supplement: Ginger | Experimental | Dietary Supplement: Ginger |
| Dietary supplement: Rosemary | Experimental | Dietary Supplement: Rosemary |
| Dietary supplement: Black pepper | Experimental | Dietary Supplement: Black pepper |
| Dietary supplement: Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 40-70 yrs
- Men and postmenopausal women
- Waist girth >102cm (men) or >88cm (women)
- LDL-C > 2.8 mmol/L
- Framingham 10-yr risk score < 10%
Key exclusion criteria (8 listed)
- Medication for lipid, hypertension, diabetes
- History of CVD, diabetes, other endocrines disorders
- Pre-menopausal women
- Alcohol consumption > 1 drink per day
- Unusual dietary habits (e.g. vegetarism)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cinnamon2.8g/day of cinnamon in capsules during 4 weeks. | Dietary supplement | Dietary supplement: Cinnamon |
| Oregano2.8g/day of oregano in capsules during 4 weeks. | Dietary supplement | Dietary supplement: Oregano |
| Ginger2.8g/day of ginger in capsules during 4 weeks. | Dietary supplement | Dietary supplement: Ginger |
| Rosemary2.8g/day of rosemary in capsules during 4 weeks. | Dietary supplement | Dietary supplement: Rosemary |
| Black pepper2.8g/day of black pepper in capsules for 4 weeks. | Dietary supplement | Dietary supplement: Black pepper |
| Placebo2.8 g/day of placebo in capsules (corn starch) during 4 weeks. | Dietary supplement | Dietary supplement: Placebo |
Primary outcome
Endothelial function measured by endopat system (the endothelium-mediated changes in vacular tone)
Time frame: at week 0 and week 4
3 secondary outcomes
Circulating level of plasma lipoproteins-lipids
Time frame: at week 0 and week 4
Oxidative stress
Time frame: at week 0 and week 4
Endothelial activation and inflammatory markers
Time frame: at week 0 and week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
- Derived from this study: PubMed 24292639Carnovale V, Paradis ME, Gigleux I, Ramprasath VR, Couture P, Jones PJ, Lamarche B, Couillard C. Correlates of reactive hyperemic index in men and postmenopausal women. Vasc Med. 2013 Dec;18(6):340-6. doi: 10.1177/1358863X13507975.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Couillard, Ph.D principal investigator
Laval University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cinnamon, Oregano and Ginger in people with Endothelial Function, run by Laval University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function measured by endopat system (the endothelium-mediated changes in vacular tone) (time frame: at week 0 and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01085019, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2012.